Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Population Council

Other / NIH

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Other

Contraceptive efficacy provided by the daily application of NES/T gel for 52 weeks during the efficacy phase of the study determined using Kaplan-Meier methods to estimate the 12 month cumulative pregnancy probability in the typical use population.

Suppression of spermatogenesis induced by daily use of the NES/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the suppression phase of the study.

Maintenance of suppression of spermatogensis induced by daily use of the NE/T gel as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL during the 52 week efficacy phase of the study.

(and 24 more...)

420

All

18 Years to 50 Years (Adult)

NCT03452111

CCN017

June 2018

July 2021

September 2021

March 2, 2018

March 2, 2018

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical CenterTorrance, California, United States

University of KansasKansas City, Kansas, United States

University of Washington Medical Center & Health SciencesSeattle, Washington, United States